Non-invasive assessment of intra-amniotic environment
AssigneeCiphergen Biosystems, Inc.
InventorsIrina Buhimschi, Robert Christner, Catalin Buhimschi, Carl Weiner
Life of this patent
Estimating the term…
Abstract
Assessing fetal health and maturity, and the integrity and health of the amnion, is effected via protein profiling of vaginal fluid, thereby to identify various abnormal conditions during pregnancy. This approach also provides a means for gauging the duration and/or magnitude of intraamniotic/fetal inflammation that occurs during pregnancy.
Claims55
A method for assessment of the intra-amniotic environment, comprising (A) obtaining a vaginal sample from a subject, and (B) subjecting the sample to analysis, to determine presence or absence in the sample of a plurality of biomarkers that is indicative of status of the intra-amniotic environment, such that results from the assessment of the vaginal sample informs a diagnostic or prognostic determination in relation to the subject.
A method for assessment of the intra-amniotic environment, comprising (A) obtaining a vaginal sample from a subject, (B) subjecting the sample to analysis, to determine the presence or absence in the sample of one or more oxidized or carbonylated peptides that are indicative of status of the intra-amniotic environment, such that results from the assessment of the vaginal sample informs a diagnostic or prognostic determination in relation to the subject.
A method for qualifying status of the intra-amniotic environment in a subject over time, comprising (i) providing spectra generated by mass spectrometric analysis of at least two vaginal samples taken from the subject, and (ii) extracting data from the spectra and subjecting the data to pattern-recognition analysis that is keyed to at least two peaks in the spectra.
A kit for detecting, from a sample of vaginal fluid, the presence of at least two biomarkers indicative of status of the intra-amniotic environment, comprising (a) a substrate adapted for inserting into a mass spectrophotometer for analysis, and (b) instructions for applying a sample of vaginal fluid to the substrate and subjecting the substrate to mass spectrometric analysis.
A kit for detecting, from a sample of vaginal fluid, the presence of at least one oxidized or carbonylated peptide indicative of status of the intra-amniotic environment, comprising (a) a substrate that binds the peptide, and (b) instructions for applying a sample of vaginal fluid to the substrate and subjecting the substrate to analysis.
A method for identifying biomarkers that are present in vaginal fluid and are indicative of status of the intra-amniotic environment, comprising:
- (a) profiling a sample of vaginal fluid by mass spectrophotometric analysis,
- (b) profiling a sample of amniotic fluid by mass spectrophotometric analysis, and
- (c) comparing the profiles obtained in (a) and (b) to identify biomarkers in vaginal fluid that also are found in amniotic fluid.
A method for identifying biomarkers that are present in vaginal fluid and are indicative of status of the intra-amniotic environment, comprising:
- (a) profiling a first sample of vaginal fluid from a subject having a normal pregnancy by mass spectrophotometric analysis,
- (b) profiling a second sample of vaginal fluid from a subject having a pregnancy characterized by an abnormal clinical status by mass spectrophotometric analysis, and
- (c) correlating the presence or absence of the biomarkers in the vaginal fluid to clinical status of the pregnancy.
Dependencies are inferred from the claim text.